Guest Post from Kenneth Stein, MD, FACC, FHRS
Chief Medical Officer
Rhythm Management Division at Boston Scientific Corporation, a global medical technology company which manufactures the Watchman LAAC Device.
Atrial fibrillation (AF) affects nearly nine percent of all Medicare beneficiaries and represents a significant source of stroke burden.[i] AF patients are five times more likely to suffer a stroke than non-AF patients, and the strokes are twice as likely to be fatal or severely disabling.[ii] [iii] Stroke is considered the most severe and debilitating consequence of AF, with many patients ranking the resultant disability worse than death.[iv] Medicare is estimated to spend $16 billion annually on AF, with nearly half of this expenditure resulting from AF-related strokes.[v] Given the clinical and financial toll of stroke, the prevention of stroke, and AF-associated strokes specifically, is a high priority for healthcare providers and policymakers.
Warfarin has long been the established standard of care for stroke prophylaxis in non-valvular AF. While effective at reducing the risk of stroke, it is of necessity associated with an increased risk of bleeding, resulting in lower quality of life and high patient non-adherence.[vi] [vii] [viii] Recent advances in stroke prevention in AF have resulted in new treatment alternatives. Several novel oral anticoagulants (NOACs) have been shown to be non-inferior to warfarin for stroke risk reduction and are approved for use in the United States.[ix] [x] [xi] [xii] Similar to warfarin, they are associated with a risk of major bleeding complications and their effectiveness is dependent on patient adherence with therapy: more than 20 percent of NOAC trial patients discontinued the therapy within two years of initiation. Percutaneous left atrial appendage closure (LAAC) is a device-based alternative to chronic pharmacological therapy for stroke risk reduction in AF and was recently established as a new therapeutic class in the US with the FDA approval of the WatchmanTM LAAC Device.[xiii]
While a growing body of evidence supports the clinical benefits of NOACs and LAAC relative to warfarin in appropriate patients,[xiv] [xv] it is also important to understand the economic value that the therapies provide. In recent years, LAAC has been shown to be cost effective and cost saving for Medicare relative to warfarin in a relatively short period of time.[xvi] [xvii] [xviii] Furthermore, it is estimated that the LAAC strategy results in lower Medicare beneficiary out-of-pocket costs than warfarin, dabigatran or rivaroxaban within two years’ time of initiating therapy.[xix] While the cost of warfarin treatment itself is low, the high rate of bleed-related complications drives up the cost of care over time, rapidly eroding the initial cost benefit of warfarin therapy. In contrast, the device-based approach requires a higher upfront investment, as the costs for the device and procedure are borne in the first year of treatment, but costs thereafter are relatively modest.
The higher upfront investment may pose a challenge to some hospitals. Fortunately, there is an existing policy that can reduce the upfront cost for hospitals, Medicare’s new technology add-on payment (NTAP). LAAC is exactly the type of new therapy that policymakers had in mind when developing the NTAP. We will learn soon whether the Center for Medicaid and Medicare Services (CMS) approves a request that hospitals receive new technology add-on payments for LAAC therapy during the next two years.
LAAC is an innovative therapy and a meaningful advance to reduce the risk of stroke in high risk patients with non-valvular AF who are deemed suitable for warfarin but who have an appropriate rationale to seek a non-pharmacologic alternative. This device-based approach represents a significant change to the way doctors and payers manage and pay for stroke risk reduction in AF. Doctors and patients will be challenged to determine which therapy is best on an individual basis. Similarly, payers will be challenged with how to appropriately recognize the long-term benefits of LAAC and adequately reimburse hospitals and physicians providing this ground-breaking, device-based therapy. LAAC provides long-term clinical and economic benefits relative to warfarin and should be considered as a viable option by providers and payers for appropriate patients.
Opinions contained in this guest blog represent the authors and are not necessarily those of the AANS and CNS.
[i] Piccini JP et al. Incidence of prevalence of atrial fibrillation and associated mortality among Medicare beneficiaries: 1993-2007. Circ Cardiovasc Qual Outcomes 2012;5:85-93.
[ii] P A Wolf, R D Abbott and W B Kannel. Atrial Fibrillation as an Independent Risk Factor for Stroke: The Framingham Study. Stroke. 1991;22:983-988.
[iii] Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:528–536.
[iv] Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857e67.
[v] Lee WC, Lamas GA, Balu S, Spalding J, Wang Q, Pashos CL. Direct treatment cost of atrial fibrillation in the elderly American population: a Medicare perspective. J Med Econ. 2008;11:281–298.
[vi] Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857e67.
[vii] Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B, Placebo-controlled, Randomized Trial of Warfarin and Aspirin for Prevention of Thromboembolic Complications in Chronic Atrial Fibrillation. Lancet 1989; 1(8631):175-9.
[viii] Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S. Major Hemorrhage and Tolerability of Warfarin in the First Year of Therapy Amoung Elderly Patients with Atrial Fibrillation. Circulation 2007;115:2689-2696.
[ix] Connelly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J et al, Dabigatran versus Warfarin in Patients with Atrial Fibrillation, New Eng J Med 2009;361:1139-1151.
[x] Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Werner H et al, Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. New Engl J Med 2011:365:883-891.
[xi] Granger CB, Alexander JH, McMurray JJV, Lopes RD, Hylek EM, Hanna M et al, Apixaban versus warfarin in patients with atrial fibrillation. New Engl J Med 2011; 365:981-992.
[xii] Guigliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL et al, Edoxaban versus warfarin in patients with atrial fibrillation. New Eng J Med 2013;369:2093-104.
[xiv] Reddy VY, Sievert H, Halperin J, et al, Percutaneous left atrial appendage closure vs. warfarin for atrial firbillation: a randomized controlled trial. JAMA 2014;312(19):1988-1998.
[xv] Holmes DR, Kar S, Price MJ, Whisenant B, Sievert H, Doshi S, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy. JACC. 2014;64:1-12.
[xvi] Reddy VY, Akehurst RL, Amorosi SL, Armstrong S, Taggart C, Beard S, Knight C, Holmes DR. Cost utility and quality of life impact of left atrial appendage closure compared to warfarin for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2014;63(12_S):A353.
[xvii] Yan, B., Innes, C., Lam, Y. et al. (2012) Cost-effectiveness of transcatheter left atrial appendage occlusion compared with 5 alternative anticoagulation strategies for stroke prevention in atrial fibrillation: A markov decision analysis. J Am Coll Cardiol. 2014;60(17B):26.
[xviii] Armstrong SO, Amorosi SL, Garfield SS, Stein K. Medicare budget implications of left atrial appendage closure for stroke risk reduction in non-valvular atrial fibrillation. Circulation. 2014;130:A16185.
[xix] Armstrong S, Amorosi SL, Patel P, Erickson GC, Stein K. An analysis of patient out-of-pocket spending for stroke prevention in non-valvular atrial fibrillation. J Am Coll Cardiol. 2014;63(12_S):A349.